Claret Medical Seeks FDA Clearance of Sentinel Cerebral Protection System for TAVR

September 20, 2016—Claret Medical, Inc. announced the filing of a marketing application with the US Food and Drug Administration (FDA) for clearance of its Sentinel cerebral protection system (CPS) for use during transcatheter aortic valve replacement (TAVR). The Sentinel CPS received European CE Mark approval in 2013.

According to the company, the FDA filing includes data from the recently completed SENTINEL pivotal trial, conducted under an FDA investigational device exemption. The prospective, randomized, controlled, blinded SENTINEL trial, which commenced in October 2014, enrolled 363 TAVR patients at 19 centers in the United States and Germany. Trial endpoints included reduction in new ischemic cerebral infarcts, major adverse cardiac or cerebrovascular events, neurocognitive outcomes, and qualitative and quantitative histopathological findings. The SENTINEL trial allowed inclusion of all commercially available TAVR platforms available in the United States.

On September 14, Claret Medical announced that data from the pivotal SENTINEL trial will be presented during a Late-Breaking Clinical Trial session at TCT 2016, the 28th Transcatheter Cardiovascular Therapeutics scientific symposium, being held October 29 to November 2 in Washington, DC. The SENTINEL results will be presented by Coprincipal Investigator Susheel Kodali, MD, of Columbia University Medical Center/New York-Presbyterian Hospital, on Tuesday, November 1 at 9:00 AM in the Main Arena.

Claret Medical advised that results from the recently published CLEAN-TAVI (Claret Embolic Protection and Transcatheter Aortic Valve Implantation) blinded, randomized controlled trial and the MISTRAL-C randomized controlled trial showed that patients protected with the system had significantly fewer and smaller new ischemic cerebral infarcts following the procedure than unprotected patients. MISTRAL-C also demonstrated that the TAVR procedure created embolic debris in 100% of patients, which could have traveled to the brain if not for the protection of the Sentinel CPS. The MISTRAL-C data were published in July by Nicolas M. Van Mieghem, MD, et al in Eurointervention (2016;12:499–507). In August, findings from CLEAN-TAVI were published by Stephan Haussig, MD, et al in the Journal of the American Medical Association (2016;316:592–601).